ECSP21067816A - PHARMACEUTICAL FORMULATIONS - Google Patents

PHARMACEUTICAL FORMULATIONS

Info

Publication number
ECSP21067816A
ECSP21067816A ECSENADI202167816A ECDI202167816A ECSP21067816A EC SP21067816 A ECSP21067816 A EC SP21067816A EC SENADI202167816 A ECSENADI202167816 A EC SENADI202167816A EC DI202167816 A ECDI202167816 A EC DI202167816A EC SP21067816 A ECSP21067816 A EC SP21067816A
Authority
EC
Ecuador
Prior art keywords
pharmaceutical formulations
preparing
processes
treatment
polyethylene glycol
Prior art date
Application number
ECSENADI202167816A
Other languages
Spanish (es)
Inventor
Audrey Antoinette Renée Lathuile
Rene Holm
Kristof Leonard Kimpe
Hana Prokopcová
Thomas Eddy R Neefs
Sanket Manoj Shah
Original Assignee
Janssen Pharmaceutica Nv
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Janssen Pharmaceutica Nv filed Critical Janssen Pharmaceutica Nv
Publication of ECSP21067816A publication Critical patent/ECSP21067816A/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816—Wall or shell material
    • A61K9/4825—Proteins, e.g. gelatin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/472—Non-condensed isoquinolines, e.g. papaverine
    • A61K31/4725—Non-condensed isoquinolines, e.g. papaverine containing further heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/415—1,2-Diazoles
    • A61K31/4155—1,2-Diazoles non condensed and containing further heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816—Wall or shell material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4833—Encapsulating processes; Filling of capsules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

La invención se refiere a formulaciones farmacéuticas que comprenden un principio farmacéutico activo, un polietilenglicol que tiene un punto de congelación de al menos aproximadamente 30 ºC y un inhibidor de la tasa de cristalización. También se describen formas farmacéuticas sólidas que comprenden dichas formulaciones farmacéuticas, procesos para prepararlas y su uso en métodos de tratamiento.The invention relates to pharmaceutical formulations comprising an active pharmaceutical ingredient, a polyethylene glycol having a freezing point of at least about 30°C, and a crystallization rate inhibitor. Solid dosage forms comprising said pharmaceutical formulations, processes for preparing them and their use in methods of treatment are also described.

ECSENADI202167816A 2019-02-22 2021-09-14 PHARMACEUTICAL FORMULATIONS ECSP21067816A (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN2019075844 2019-02-22

Publications (1)

Publication Number Publication Date
ECSP21067816A true ECSP21067816A (en) 2021-12-30

Family

ID=69650609

Family Applications (1)

Application Number Title Priority Date Filing Date
ECSENADI202167816A ECSP21067816A (en) 2019-02-22 2021-09-14 PHARMACEUTICAL FORMULATIONS

Country Status (21)

Country Link
US (1) US20220175760A1 (en)
EP (1) EP3927324A1 (en)
JP (1) JP2022523371A (en)
KR (1) KR20210132099A (en)
CN (1) CN113473971B (en)
AU (1) AU2020225342A1 (en)
BR (1) BR112021016411A2 (en)
CA (1) CA3129356A1 (en)
CR (1) CR20210480A (en)
EA (1) EA202192322A1 (en)
EC (1) ECSP21067816A (en)
IL (1) IL285674A (en)
JO (1) JOP20210230A1 (en)
MA (1) MA55015A (en)
MX (1) MX2021010144A (en)
PE (1) PE20212323A1 (en)
PH (1) PH12021552020A1 (en)
SG (1) SG11202109102PA (en)
TW (1) TW202045159A (en)
UY (1) UY38593A (en)
WO (1) WO2020169738A1 (en)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI795381B (en) 2016-12-21 2023-03-11 比利時商健生藥品公司 Pyrazole derivatives as malt1 inhibitors
US12404260B2 (en) 2019-04-11 2025-09-02 Janssen Pharmaceutica Nv Pyridine rings containing derivatives as MALT1 inhibitors
EP4199911A1 (en) * 2020-08-21 2023-06-28 JANSSEN Pharmaceutica NV Pharmaceutical formulations comprising a malt1 inhibitor and a mixture of polyethylene glycol with a fatty acid
JP2023539729A (en) 2020-08-21 2023-09-19 ヤンセン ファーマシューティカ エヌ．ベー． Amorphous forms of MALT1 inhibitors and their formulations
KR20230154227A (en) * 2021-03-03 2023-11-07 얀센 파마슈티카 엔브이 A therapeutically effective dose of the MALT1 inhibitor JNJ-67856633 (1-(1-oxo-1,2-dihydroisoquinolin-5-yl)-5-(trifluoromethyl)-N-(2-(trifluoromethyl) Methods of treating conditions using methyl)pyridin-4-yl)-1H-pyrazole-4-carboxamide)
JP2025501056A (en) * 2021-12-30 2025-01-17 シャンハイ ハンソー バイオメディカル カンパニー リミテッド Tricyclic derivative inhibitors, their preparation and application
AU2024357109A1 (en) 2023-10-06 2026-03-12 Ionctura Sa Combination of roginolisib with a malt1-gls inhibitor

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6248363B1 (en) * 1999-11-23 2001-06-19 Lipocine, Inc. Solid carriers for improved delivery of active ingredients in pharmaceutical compositions
WO2006037348A1 (en) * 2004-10-01 2006-04-13 Lifecycle Pharma A/S Pharmaceutical compositions comprising fenofibrate and a statin
EP2395838B1 (en) * 2009-02-11 2018-07-25 Cadila Pharmaceuticals Ltd. Stable pharmaceutical composition for atherosclerosis
TW201040181A (en) * 2009-04-08 2010-11-16 Idenix Pharmaceuticals Inc Macrocyclic serine protease inhibitors
US8252821B2 (en) * 2009-04-14 2012-08-28 Bristol-Myers Squibb Company Bioavailable capsule compositions of amorphous alpha-(N-sulfonamido)acetamide compound
MA37711A1 (en) * 2012-06-04 2017-05-31 Pharmacyclics Inc Crystalline forms of a crude tyrosine kinase inhibitor
IL315294A (en) * 2015-03-03 2024-10-01 Pharmacyclics Llc Pharmaceutical formulations of bruton's tyrosine kinase inhibitor
CN107296807B (en) * 2016-04-15 2020-03-20 中国科学院上海生命科学研究院 Application of MALT1 targeted inhibitor in preparation of MALT 1-dependent tumor treatment drug
TWI795381B (en) * 2016-12-21 2023-03-11 比利時商健生藥品公司 Pyrazole derivatives as malt1 inhibitors

Also Published As

Publication number Publication date
SG11202109102PA (en) 2021-09-29
CN113473971A (en) 2021-10-01
MX2021010144A (en) 2021-09-14
EP3927324A1 (en) 2021-12-29
CN113473971B (en) 2024-07-02
EA202192322A1 (en) 2021-12-03
AU2020225342A1 (en) 2021-08-19
KR20210132099A (en) 2021-11-03
IL285674A (en) 2021-10-31
CR20210480A (en) 2021-11-10
JP2022523371A (en) 2022-04-22
PE20212323A1 (en) 2021-12-14
PH12021552020A1 (en) 2022-09-12
US20220175760A1 (en) 2022-06-09
MA55015A (en) 2021-12-29
UY38593A (en) 2020-08-31
WO2020169738A1 (en) 2020-08-27
CA3129356A1 (en) 2020-08-27
JOP20210230A1 (en) 2023-01-30
BR112021016411A2 (en) 2021-10-13
TW202045159A (en) 2020-12-16

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